Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder

• Status: Not yet recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: All

Summary

Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Bupropion

Criteria

Inclusion Criteria:

• Male or female outpatients aged ≥7 to <18 years (at Screening Visit 1).

• Provide assent (subject) and written informed consent (parent/legal representative) and Health Insurance Portability and Accountability Act (HIPAA) for study participation (at Screening Visit 1).

• Meet diagnostic criteria for MDD as defined in the DSM IV-TR5 at Screening Visits 1 and 1a (K-SADS-PL; see Appendix 17.2).

• Current depressive episode of at least 4 weeks' duration as noted in the subject's history (Screening Visit 1).

• Total CDRS-R raw score ≥45 at both the Screening and Baseline Visits (Visits 1 and 2) (see Appendix 17.3).

• CGI-S score of ≥4 at the Baseline Visit (Visit 2) (see Appendix 17.4).

Exclusion Criteria:

• are unable to swallow medications without difficulty

• have known hypersensitivity to bupropion hydrobromide

• are pregnant or planning to get pregnant or are lactating

• Women of childbearing age unable to use at least one method of effective contraception for the duration of the study

• Previous history of attempted suicide

• are unable to understand and communicate effectively with parent, Investigator, and study coordinator

• are at immediate risk of requiring hospitalization, in the Investigator's opinion

• have current seizure disorder or history of seizures or head trauma

• have history or presence of clinically significant medical conditions or clinically important laboratory abnormalities

• have ECG or physical examination abnormality at screening

• have body weight less than the 3rd percentile or greater than the 97th percentile for age.